Assessment of Safety,efficacy of Liposomal Amphotericin B (AmBisome) Vs Miltefosine 12 weeks therapy in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL)-an observational pilot study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of AmBisome 30 mg/kg total dose (5 mg/kg X 6 infusions twice weekly) Vs Miltefosine ( 2.5 mg/kg or 100 mg/day) 12 weeks therapy in PKDL patients.
研究概览
简要总结
PKDL is a dermal form of leishmaniasis caused by protozoal parasite Leishmania donovani, spread through the bite of infected female Phlebotomine sand flies. It is characterized by macular, papular, or nodular lesions or a mixture of these. There are very limited drugs available for the treatment of PKDL.The present treatment guideline includes miltefosine in the dose of 2.5mg/kg/day or 100mg/day for 12 weeks. However, this drug is associated with gastrointestinal side effects and contraindicated in pregnant and nourishing women due to its teratogenic effect.Recently a study by Ramesh et. al reported that the efficacy of miltefosine is decreasing substantially in the treatment of PKDL with a cure rate of 85%. The other alternative treatment is with amphotericin B in the dose of 1mg/kg in 5% dextrose IV, alternate days for 15 injections in 3 to 4 courses at fifteen days intervals .This treatment regimen is very lengthy, requires prolonged hospitalization and has severe side effects including nephrotoxicity and hypokalemia. Liposomal formulation of amphotericin B has a longer half life, less toxic and recommended by WHO for elimination of VL from the Indian subcontinent. Liposomal amphotericin B at 2.5mg/kg for 20 days was tried in Sudanese PKDL.Cure rate was 83% and no adverse events were reported, Similarly a study was done in Bangladesh with Ambisome by MSF(unpublished). Despite high endemicity of the disease in India no study was done on PKDL with Ambisome. Therefore, we aimed to assess the efficacy and safety of Liposomal Amphotericin B in the treatment of PKDL in Bihar and compare it with the standard treatment of PKDL with Miltefosine 2.5 mg/kg body weight or 100 mg/day for 12 weeks. This study can proved to be one of the benchmark for establishing an effective, safe and shorter duration treatment for PKDL in the Indian subcontinent, which in turn will be of great help for the kalaazar elimination program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged 5- 65 years Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis.
- •Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies and qPCR).
排除标准
- •Pregnant and lactating female Patients not willing to participate.
- •Thrombocyte count <100 x 1000000000/l Leukocyte count <2.5 x 1000000000/l Hemoglobin < 8.0 g/100 ml ASAT, ALAT, AP >3 times upper limit of normal range Bilirubin >2 times upper limit of normal range HbsAg, HCV and HIV positive Serum creatinine or BUN >1.5 times upper limit of normal range Hypersensitivity to AmBisome or inactive ingredients of AmBisome and Miltefosine.
- •Patients not willing to take contraceptive measures during study duration.
结局指标
主要结局
To evaluate the effectiveness of AmBisome 30 mg/kg total dose (5 mg/kg X 6 infusions twice weekly) Vs Miltefosine ( 2.5 mg/kg or 100 mg/day) 12 weeks therapy in PKDL patients.
时间窗: To evaluate the effectiveness of AmBisome 30 mg/kg total dose (5 mg/kg X 6 infusions twice weekly) Vs Miltefosine ( 2.5 mg/kg or 100 mg/day) 12 weeks therapy in PKDL patients.
次要结局
- To assess the adverse events and serious adverse events of the two different regimens(To assess the rates of relapse after initial response)